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NCT00127634 · ClinicalTrials.gov registry record · Phase 3
Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes
A Phase 3 study of Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 385
- Enrollment target
- 20
- Study locations
NCT00127634: Completed Phase 3 study of Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company.
NCT00127634 is a Phase 3 study of Diabetes Mellitus, Type 1 that has completed, run by Eli Lilly and Company. The registered enrollment target is 385 participants, below the 1,263-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00127634, a Phase 3 study of Diabetes Mellitus, Type 1, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 385 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.
Conditions Studied
Interventions
- DRUG Insulin Glargine
- DRUG Human Insulin Inhalation Powder
- DRUG Injectable Insulin
Study Locations (20)
Florida
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Hollywood
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Jacksonville
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Largo
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - New Port Richey
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - West Palm Beach
California
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Sacramento
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Walnut Creek
Colorado
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Aurora
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Denver
Illinois
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Chicago
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Springfield
Delaware
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Newark
Georgia
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Atlanta
Idaho
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Idaho Falls
Indiana
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 385 participants |
| Start Date | 2005-07 |
| Est. Completion | 2008-05 |
| Phase | Phase 3 |
What the finished NCT00127634 record still lists
NCT00127634 is an interventional study that assigns participants to a tested intervention. The registered 385 participants enrollment target is mid-sized for trials with a published cap, below the 1,263-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 3 interventions - of which Insulin Glargine is the first listed.
NCT00127634 names 20 study sites across 13 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT00127634 about?
NCT00127634 is a clinical study titled "Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes". This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.
What is the current status of trial NCT00127634?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 385 participants. The study started on 2005-07. Estimated completion is 2008-05.
What conditions does trial NCT00127634 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT00127634?
The interventions under investigation include: Insulin Glargine (DRUG), Human Insulin Inhalation Powder (DRUG), Injectable Insulin (DRUG).
Who is sponsoring clinical trial NCT00127634?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00127634 being conducted?
This trial has 20 study locations across California, Colorado, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00127634's enrollment target sits among peer trials
385 19th of 118 higher than 100 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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